Nonaugmentive mastopexy

ABSTRACT

Disclosed are methods and devices for minimally invasive mastopexy, or other soft tissue suspension, which may be accomplished with our without augmentation.

PRIORITY INFORMATION

This application claims priority under 35 U.S.C. §120 as a continuationapplication of U.S. patent application Ser. No. 14/752,583 filed on Jun.26, 2015, which in turn is a continuation of U.S. patent applicationSer. No. 14/498,940 filed on Sep. 26, 2014, which was in turn acontinuation application of U.S. patent application Ser. No. 13/936,945filed Jul. 8, 2013, which is a continuation application of U.S. patentapplication Ser. No. 11/782,839 filed Jul. 25, 2007, and is now issuedas U.S. Pat. No. 8,480,557 issued Jul. 9, 2013, which in turn claims thebenefit under 35 U.S.C. §119 as a nonprovisional application of U.S.Provisional Patent Application Ser. No. 60/820,565, filed Jul. 27, 2006.All of the aforementioned priority applications are hereby incorporatedby reference in their entireties.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to apparatus and methods for mastopexy or“breastlift” procedures and devices, and more particularly to devicesand methods for minimally invasive mastopexy which may be accomplishedwith or without augmentation.

Description of the Related Art

Breast augmentation, reduction and reconstructive surgeries have becomecommonplace within the last twenty years. In a breast augmentationprocedure, a breast prosthesis is implanted into the chest to enhancethe apparent size of the naturally occurring breast tissue. In a breastreconstructive procedure, a breast prosthetic is used to replace thediseased breast tissue after the diseased breast tissue has beensurgically removed.

Breast augmentation procedures and breast reconstructive proceduresusually are performed using one of three common surgical techniques. Thesimplest of the surgical techniques is that used in the “over themuscle” breast augmentation procedure. Using such a technique, a singlebreast prosthesis is placed between the pectoral muscle in the chest andthe mammary glands. In such a procedure, the breast prosthesis is incomplete contact with the breast tissue, but is unsupported by anymuscle.

A second technique used in breast augmentation surgery is a partialsubmuscular implant procedure. In this procedure, a breast prosthesis isplaced partially under the pectoral muscle through either an incision inthe nipple or an inframammary crease incision. During surgery, themuscle support fascia at the bottom of the pectoral muscle is disruptedand the breast prosthesis is partially inserted under the muscle. Theresult is that the top of the breast prosthesis is covered by thepectoral muscle and the bottom is not. This allows the bottom of theaugmented breast to appear round while the top of the chest appears morenatural.

A third technique used in breast surgery is the completely under themuscle technique. In this technique, the intra-muscle support fascia ofthe pectoral muscle is not cut. Rather, the breast prosthesis is placedentirely under the pectoral muscle and is supported by the muscle faciaat the bottom.

Another procedure in the evolving field of cosmetic surgery involvesmastopexy or “breastlift” surgery. Factors such as pregnancy, nursing,physical activity, time, gravity, and the like may affect skin thicknessand tone. As skin loses elasticity, shape and firmness consequentlydecline over time. Breastlift, or mastopexy, is a surgical procedure toraise and reshape breasts. In conventional mastopexy, bio-compatibleimplants are often inserted under muscle, or under mammary tissues abovemuscle in order to alter both firmness and size. Mastopexy incombination with augmentation can be seen, for example, in US patentPublication No. 2006/0036333 A1, to Smith, et al.

Notwithstanding the foregoing developments, however, there remains aneed for a minimally invasive system for accomplishing mastopexy toresolve or address ptosis, particularly in patients who do not desire anaccompanying augmentation.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the present inventiona minimally invasive mastopexy system. The system comprises a softtissue support sling, and an elongate tubular introducer. The introducerhas a proximal end, a distal end and a central lumen for removablyreceiving the support sling. At least one bone anchor is provided, foranchoring the support sling to bone.

The minimally invasive mastopexy system may additionally comprise asecond bone anchor, and either or both bone anchors are provided with aconnector for adjustable connection to the sling. The support sling mayadditionally comprise a proximal support line and a distal support linefor suspending the sling from the anchors. The mastopexy system mayinclude at least one strain relief, on the sling or the support lines,for permitting elastic stretching and return of the support sling.

The introducer may be a tunneling sheath, for tunneling through softtissue. The introducer may be provided with a plurality of aperturesthrough the side wall, and in communication with the central, lumen, forinfusion of media such as drugs or local anesthesia into adjacenttissue. The system may include a separate tunneling sheath, in additionto the tubular introducer.

In some embodiments, the system may include at least a first and asecond soft tissue support sling. The first soft tissue support slingmay be a different size than the second soft tissue support sling.

Further features and advantages of the present invention will becomeapparent from the detailed description of preferred embodiments whichfollows, when considered together with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B demonstrates the overall goal of the technique to change anipple with ptosis (FIG. 1B) to a nipple that points up (FIG. 1A). Areference line drawn orthogonal to the chest wall illustrates superiorelevation of the repositioned breast mass in FIG. 1A compared to FIG.1B.

FIG. 2 is a side elevational, schematic view of an implant assembly inaccordance with one embodiment of the present invention.

FIG. 3 is a cross sectional view taken along the line 3-3.

FIGS. 4A-D demonstrate the technique of in situ bending of the malleabletunneling tube as it is gently guided through the breast tissue formingalmost a u-shape to get from its insertion site in the axilla into themedial aspect of the clavicle or even to the sternum through thesubcutaneous tissue.

In FIG. 4A, the tunneling tube is being placed into the axilla. In FIG.4B, the tube has been advanced around and the steerable needle has beenused to access the bony anchor on the medial aspect of the sternum. InFIG. 4C the tube is being gently withdrawn as the leading edge supportline is fixed manually to the medial aspect of the sternum and the slingis being deployed in the breast tissue. In FIG. 4D the tunneling fromthe axillary entry site to the lateral bone anchor of the clavicle hasbeen performed and the tailing edge support line has now been placedthrough the subcutaneous tissue and attached to the bone anchor.

FIG. 5 demonstrates the sling in place and gives an anterior-posteriorview. The support lines are schematically shown with their built inspring constants to help in the dynamic nature of the sling.

FIG. 6 is a lateral view of the assembly shown in FIG. 5, showing thedynamic response of the illustrated embodiment.

FIGS. 7A through 7C illustrate different chest wall attachmentstructures.

FIG. 8A is an anterior-posterior view showing an access incisionlocation.

FIG. 8B is a lateral view of the incision location of FIG. 8A.

FIG. 9 is a schematic illustration of a blunt dissector tool positionedwithin the incision 8A.

FIG. 10 illustrates deployment of the anchoring ring illustrated in FIG.7A.

FIG. 11 illustrates potential locations on the chest wall for theanchors illustrated in FIGS. 7A through 7C.

FIG. 12 is an anterior-posterior view of the support ring of FIG. 7A,with a first soft tissue suspension structure attached.

FIG. 13 is an anterior-posterior view of the support ring of FIG. 7A,with a second type of soft tissue attachment structure attached.

FIG. 14A is a fragmentary, schematic view of an adjustment structuresuch as a pulley attached to a support ring.

FIG. 14B is an enlarged view of the pulley of FIG. 14A.

FIG. 15 is a fragmentary schematic representation of the boney anatomyavailable for attachment.

FIG. 16 illustrates the boney anatomy of FIG. 15, and a plurality ofpotential attachment points along the clavical, for achieving differentsupport vectors.

FIG. 17 is an anterior-posterior view illustrating a type of soft tissueanchor.

FIG. 18 is an anterior-posterior view illustrating a further supportsystem.

FIG. 19 schematically illustrates a springy, strain relief functionbetween a boney attachment point X₅ and a supported mass X₆.

FIG. 20 is an anterior-posterior view of a mastopexy system havingstrain relief capability.

FIG. 21A is a schematic illustration of a mesh soft tissue anchor in anunconstrained configuration.

FIG. 21B is a schematic illustration of the mesh tissue anchor of FIG.21A, compressed within a deployment sleeve.

FIGS. 22A and 22B are schematic illustrations of a tissue grabbinganchor, in an open and closed configuration, respectively.

FIG. 23 is an anterior-posterior view of a mastopexy construct inaccordance with the present invention.

FIG. 24A illustrates a multifilament anchor attached to a support tube.

FIG. 24B illustrates the multifilament anchor of FIG. 24A, constrainedwithin a delivery tube.

FIG. 24C illustrates the multifilament anchor of FIGS. 24A and 24B,deployed within soft tissue.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Surgical techniques for breast reduction and reshaping have not changedsignificantly over the past generation. As breasts age, the trajectoryof the nipple relative to the body axis changes. The pendulous mass ofareolar tissue also descends causing a change in nipple line relative tothe rib cage.

The present invention provides percutaneous, minimally invasivetechnologies for tissue reorientation and specifically in connectionwith mastopexy. This involves elevating the trajectory of the nipplerelative to the chest wall, as well as the position of the pendulous onthe chest wall. It can also be applied to buttocks lifts or any othertype of soft tissue suspension or reorientation. Potential applicationsinclude breast ptosis, buttocks ptosis, and gullet suspension. Inaddition, the implant of the present invention can be positioned toachieve suspension and/or stabilization of the loose connective tissueon the upper arm and more specifically to the soft tissue over thetriceps muscle.

Breast ptosis is an interesting phenomenon that occurs when the nippledescends on the chest wall and points downward. This occurs over aperiod of time in the normal aging process for women with moderate tolarge breasts; it occurs less so for women with small breasts.

There is also an entity called pseudoptosis where, although the nipplestays above a line drawn orthogonal to the chest wall, the pendulous ofthe breast sinks below on the chest wall. Mechanisms of the developmentof breast ptosis involve mainly changes in the anatomy of the breastmass itself as a function of time. Cooper's ligaments, which are adiffuse set of connective tissue that run throughout the breast andcannot be defined anatomically as one specific entity, tend to atrophyand stretch. This causes the pendulous to fall on the chest wall. Inaddition, the actual tissue within the breast itself, the ducts, theglands that make up a great deal of the tissue changes with time,specifically after adult menopause and this change in the substance ofthe breast tissue itself causes it to descend on the chest wall.

The likely patient population for nonaugmentive mastopexy in accordancewith the present invention includes women ages 35 to 75 with saggingbreasts. Nipples would be pointing downward, breast mass descended onthe chest wall. The skin remains cosmetically viable and there is nosignificant dermatomalacia. The likely patients are not interested inimplants whether they be silicone or saline and they do not requireaugmentation and would not consider reduction mammoplasty secondary toscarring.

One implementation of the invention provides a two attachment pointadjustable dynamic sling that is minimally invasive during placement. Itanchors at two points connected by support lines and may comprise apolymer fabric sling. It is preferably dynamic in that it will notrestrict the natural breast motion. With augmentive mastopexy or breastenlargement, the breasts can become so firm that they lose their naturalmovement. In addition, the implants of the present invention may beadjustable so that over time as the breasts continue to sag, a smalladjustment will allow them to be repositioned. This could beaccomplished noninvasively if a magnet driven winding mechanism could beincluded in the bone anchors.

In general, the implant of the present invention achieves two distincttypes of tissue reorientation on each patient. One is to relocate thecenter of the base of the breast mass to a point more superior on thethorax or cranial on the thorax. Another is to redirect the line definedby the erect nipple in relation to the chest wall. Although it would bepossible to adjust the trajectory of the nipple to any angle, we wouldimagine that an acute superior trajectory whether that be midline,medial, or lateral would look best cosmetically.

Techniques for repositioning the breast mass include several differentapproaches. One is a support ring fixed to the chest wall. Another is adynamic sling. Polymer tubes can be placed into the breast mass itselfthat would then be suspended via support lines to bone anchor points, ora Nitinol construct in the form of a mesh would act as a sling. Bonyanchor points will vary depending on the size of the breast and the bodyhabitus of the patient, but certainly anchors could be considered alongthe clavicle, along the medial aspect of the sternum, along any of theribs on the chest wall, and also the scapula. The curvature of the ribsas they go from anterior to posterior will have to be taken intoconsideration as running of suspensory cables or bone anchors isaccomplished and as different bone anchor locations are chosen.

In accordance with one specific technique of the present invention, adynamic sling with connecting support lines is anchored from bone andpositioned within the breast tissue. The support lines are preferablydynamic such as would be achieved by a Nitinol wire with small springslocated at intervals along its length. The Nitinol would be shape memoryset into a spring-like configuration with skip areas that were straight.In this way they would have a force constant that would hold the breastup and then, when the breast moved and the load increased the springswould be able to stretch and this would give the natural motion back tothe breast. Alternative biasing structures are also contemplated. Thesupporting lines can be made from alloys and metals other than Nitinol.

In accordance with a procedure of the present invention, patients wouldinitially be placed in a supine position. An incision would be made inthe vicinity of the axilla. The incision would be no more thanapproximately 1 cm. A substantially inflexible deployment tube with astylette would then be advanced into the incision. The breast would becupped in one hand and the deployment tube would be guided through thebreast mass subcutaneously by using manual palpation. The tube in itssimplest form would look like a 6 or 7 French guide sheath, possibly 8French. It would have a round tipped obturator and this would aid inblunt dissection.

Alternatively the deployment tube may comprise a metal, alloy orpolymeric composition that was malleable or configured for lateralflexibility, something similar to a tunneling obturator used to tunnelventriculperitoneal shunt from the cranil end to the abdominal incision.This deployment tube may be guided by bending in situ by manualpalpation. The tube is guided around serially from the incision sitedown, making a turn medially, and then going superiorly up again towardsthe clavicle. An incision would then be made above the clavicle at thebone anchor site of choice.

For example, one bone anchor point may be at the medial aspect of thebreast at the junction of the sternum and the clavicle, either on theclavicle or on the sternum, but normally not in the articulation ofthese two. A small incision of no more than approximately 1 cm. would bemade and blunt dissection accomplished down to the bone. The bone wouldthen be drilled. The drilled bore may be tapped and a threaded boneanchor screwed into place. The top of the bone anchor has an aperture orother connector that would accept a suture or a wire or othercorresponding connector on the sling.

Similarly, laterally a bone anchor site is chosen on the clavicleapproximately 4 cm. or so above the entry site in the axilla. Anincision would be made and a similar bone anchor would be placed. Thebone anchors would be exposed so that the clinician could not onlypalpate the bone anchor, but also under direct visualization see thebone anchor connector where the connecting support lines would have tobe placed.

The next step would be to position the implant. The implant may beloaded into the deployment tube that may already be in position. Ingeneral, the implant has an elongate body, at least one leading supportline and at least one trailing support line. The leading support linemay have a leading end comprising a steerable needle which is fed firstinto the tube. Following the steerable needle would be the leadingsupport line. This would then be connected to the leading end of theimplant body. The tailing end of the implant body is provided with oneor more support lines, which might also have needles attached to them.

Once the implant is advanced into the tube that was already in positionwith the tip of the tube in the subcutaneous tissue just inferior to theincision on the clavicle, the leading needle is advanced distally out ofthe tube where it may be manually grasped and then advanced through theaperture in the bone anchor. The leading and trailing support lineswould then be used to position the sling so that it is symmetricallydistributed in the breast. The deployment tube would then be proximallyretracted and the sling would remain in the breast tissue.

At this point, a first support line extends out of the incision wherethe medial bone anchor was placed in the clavicle/sternum area and asecond support line extends out of the incision in the vicinity of theaxilla. The lateral or axillary support line is tunneled from the axillaup to the lateral bone anchor such, as by direct vision just by takingthe needle on the proximal end of the trailing support line and runningit subcutaneously back into the axilla site and then pushing it uptowards the medial bone anchor and threading it through the bone anchorconnector.

Once both support lines are threaded through the respective bone anchorsthe patient is moved to a sitting position under general anesthesia sothe tension on the support lines can be adjusted to achieve the desiredcosmetic result. Then the support lines are locked in place to theanchors by screwing a lock nut into the hole on the bone anchor orotherwise securing the support line to the bone anchor so that it is nowfirmly secured with respect to the bone.

It is possible to adjust the position of the sling but rather thanpulling it through breast tissue, the adjustment of the sling and thepositioning of the sling should be done within the tube. Therefore, thedelivery tube placement and location within the breast mass will defineexactly where the sling winds up relative to the pendulous.

It may be necessary or desirable in some cases to use more than onesling. This could be done by using the same bone anchors more than once,so two or three or more slings are suspended from the same set of boneanchors, or it might be necessary to have bone anchors in multiple areaswith multiple slings, trying to deal with redirecting the pendulous.

There are numerous potential sites for each of the medial and lateralbone anchors. The sternal end of the clavicle may be a good site forbone anchors anywhere the mid sternum area. The first rib, lower pointson the sternum, or any of a variety of positions on any of the ribs.

Looking at sagittal sections of the chest wall, a glandular mass issuspended off the chest wall, There is a fascia that overlies thepectoralis muscles and the pectoral fascia provides an avascular planebetween the breast itself and the chest wall. The clavicle appears tocome to the surface under more fatty subcutaneous tissue and theninferior to the clavicle starts the pectoralis muscles. The ribs arebelow the pectoralis muscle and, therefore, in order to advance to thesecond rib, the third rib, etc., it would be necessary to go through thepectoralis muscle. Preferably, bone anchors are driven into the centerof the rib and away from the inferior aspect of the rib where the nerve,artery, and vein bundles run.

Supraclavicular nerves will need to be considered when doing thedissections and, in addition, the cephalic vein is in the region of theclavicle as well as the venous plexus overlying the belly of the hyoid17, which might send venous structures down towards the medial sternumthat could thwart attempts at placement of bone anchors.

Referring to FIGS. 1A and 1B, the above-mentioned changes resulting inptosis can be described in a more objective manner. A cross section of abreast 10 is shown schematically in relation to chest wall 12. Areference line 14 extends along an axis defined by the nipple 16 and isprojected back to the chest wall 12. The angle of incidence θ is onemethod for defining nipple trajectory. In FIG. 1A, the picture depicts ayoung breast prior to change in nipple trajectory. The reference line 18in FIG. 1A, is drawn between the nipple and the chest wall and definesthe intercostal level X₁ that corresponds to the nipple positionrelative to the chest wall. The round crosshatched area 20 in FIG. 1Adefines the pendulous of the breast mass, the position of which can benoted relative to the intercostal level X₁ and relative to referenceline 18.

In FIG. 1B, an aged breast is depicted. Note the reference line 22defining nipple trajectory forming angle θ₂ with the chest wall definesa vector distinctly different from reference line 14 in FIG. 1A. Infact, line 22 is inclined down and line 14 is inclined up. The line 24in FIG. 1B drawn as a perpendicular between the nipple and the chestwall is incident on the chest wall at an intercostal level X₂ well belowthat depicted as X₁ in FIG. 1A. The intercostal distance X₁ X₂ can varyby more than one intercostal level, and helps define the inferiormigration of the breast pendulous mass over time.

Present surgical techniques of mammoplasty seek to transform FIG. 1Binto FIG. 1A by a variety of techniques. All surgical techniques rely onbreast mass reduction and surgical nipple excision and reimplantation ata higher intercostal level. This results in disfiguring scars and insome cases, complete denervation of the nipple. Although nippletrajectory and the position of the pendulous relative to the chest wall,are corrected, unsightly scars and desensitization of the nipple mayresult as unwanted side effects of the cosmetic correction.

One embodiment of a device in accordance with the present invention forpercutaneous minimally invasive manipulation of nipple trajectory andposition of the pendulous mass relative to the chest wall will bediscussed below.

Referring to FIG. 2, there is illustrated an implant assembly inaccordance with one aspect of the present invention. The implant 30 isillustrated as positioned within an implant sleeve 32, the combinationof which may be positioned within an outer tunneling sheath 34 as hasbeen discussed.

In general, the implant 30 comprises a basket or sling portion 36extending between a proximal end 38 and a distal end 40. The basket 36may comprise any of a variety of configurations, depending upon thedesired clinical performance. In general, basket 36 comprises apolymeric or wire mesh, such as a woven or non-woven fabric, or aplurality of axially extending filaments, which may be connected bytransversely extending filaments. The basket 36 may be expandable from areduced cross sectional configuration for fitting within the implantsleeve 32 during delivery, and an expanded cross sectional configurationfor providing tissue support post implantation. In the reduced, deliveryconfiguration, the basket 36 will preferably fit within an implantsleeve 32 having an inside diameter of no greater than about 0.5 inches,preferably no greater than about 0.25 inches and optimally, no greaterthan about 0.125 inches. In the transversely expanded configuration, thebasket 36 may have a maximum transverse dimension of at least about 0.5inches, in some embodiments at least about 0.75 inches, and, dependingupon the desired clinical performance, at least about 1 inch or greater.

The implant 30 may be provided in graduated sizes, individually or inkits, to allow selection based upon clinical judgment in an individualimplantation. For example, in some implantations, two or three or fouror more relatively small implants 30 may be desired. In an alternateimplementation of the invention, one or two or three larger implants 30may be desired as an alternative. The selection of a particular size andnumber of implants 30 to be utilized in a particular procedure is amatter of clinical judgment, taking into account the desired cosmeticresult as well as extent of lateral dissection and other proceduralaspects that may be more or less desirable for a particular patient.

The basket 36 may comprise any of a variety of biocompatible, flexible,implantable materials as are known in the medical device arts. Forexample, any of a variety of suture materials such as polyethylene maybe used. Implantable polymers such as PEBAX, PEEK, nylon, PET, ePTFE,PTFE and the like may also be used. Elastic materials such as siliconeor latex may also be used. Alternatively, metal wire or a laser cutmetal lattice may be utilized. Suitable metals may include stainlesssteel, titanium, and a variety of shape memory metals such as alloys ofnickel and titanium (e.g., Nitinol).

The proximal end 38 of basket 36 is attached to a proximal support line42. Proximal support line 42 extends between the basket 36 and aproximal end of the implant, and may be provided with a proximal needle44. Proximal needle 44 may be convenient for facilitating tunneling ofthe proximal support line 42 from the percutaneous access point in theaxilla, to a lateral bone anchor as has been discussed.

The distal end 40 of basket 36 is provided with a distal support line 46which may also be provided with a distal needle 48. Distal needle 48 mayconveniently facilitate advance of the distal support line 46 in thedirection of the medial bone anchor as has been discussed.

The dimensions of the implant 30 may be varied considerably, dependingupon the desired cosmetic result. In general, the basket 36 may have alength within the range of from about 1 inch to about 8 inches, and, inmany embodiments, will be within the range of from about 2 inches toabout 6 inches. Alternatively, the basket 36 can extend the entirelength of the implant, such as from proximal needle 44 to distal needle48 if proximal needle 44 and distal needle 48 are initially included onthe implant 30. Proximal support line 42 and distal support line 46,when provided, may have an axial length of at least about 4 inches each,and, often at least about 8 inches or 12 inches each. The length of theimplant 30 overall, including the proximal support line 42 and distalsupport line 46 should be sufficiently long to accommodate mostpatients, as well as have sufficient excess support line length tofacilitate balancing the location of the implant 30 and securing theimplant 30 to the bone anchors as will be appreciated by those of skillin the art in view of the disclosure herein. The needles 44 and 48, andexcess support line will be severed and discarded following locking ofthe implant to the bone anchors.

The implant 30 is illustrated as positioned within an implant sleeve 32.Implant sleeve 32 comprises an elongate flexible tubular body 50, havinga central lumen 52 for slidably receiving the implant 30. Although theuse of an implant sleeve 32 is optional, it may be desirable formaintaining the basket 36 in a reduced crossing profile configurationfor implantation and positioning of the implant 30. Tubular body 50 maycomprise any of a variety of polymeric materials known in the catheterarts, such as those polymers identified above. Tubular body 50 may beformed by known extrusion techniques. Preferably, the tubular body 50will have an axial length sufficient to enclose the basket 36 and willnormally be at least about 2 inches long, often at least about 6 incheslong, and, in many embodiments, at least about 12 inches long.

The tubular body 50 may be provided with a plurality of sidewallapertures along its length, for communicating between the central lumen52 and the outside of the implant sleeve 32. In this embodiment, theproximal end of the tubular body 50 may be placed in fluid communicationwith a source of infusion media. In this construction, if the implantsleeve 32 is utilized to position the implant 30 in the absence of aseparate outer tunneling sheath 34, suitable media such as lidocainewith epinephrine may be infused through the central lumen 52 and out ofthe side apertures on a periodic or continuous basis to infiltrate theadjacent tissue throughout the procedure. In an embodiment of theinvention in which the implant sleeve 32 and/or implant 30 subassemblyis advanced though a separate outer tunneling sheath 34, the outertunneling sheath 34 may be provided with a plurality of apertures incommunication with a central lumen 35, to similarly permit infiltrationof adjacent tissue with media such as lidocaine and epinephrine.

An implantation sequence for the device illustrated in FIGS. 2 and 3 maybe understood by reference to FIGS. 4A-4D. Referring to FIG. 4A, aclavical 60 is illustrated schematically, as a reference for thelocation of the bone anchors. As will be appreciated by those of skillin the art in view of the disclosure herein, the bone anchors may besecured to any of a wide variety of locations and the examples providedherein are merely illustrative of one particular implementation of theinvention. In addition, attachment structures other than bone anchorsmay be utilized, such as by looping support lines entirely around abone, or attachment of support lines to soft tissue utilizing any of avariety of hooks, barbs, staples sutures, tissue ingrowth structures,soft tissue anchors and the like. Bone anchors are preferably preferred,due to their perceived durability.

Any of a variety of bone anchors may be utilized in the practice of thepresent invention. In general, the bone anchors will include a boneengaging portion which may be a threaded shaft, or a shaft with teeth orother textured surface, for wedging into a predrilled bore in the bone.Alternatively, bone anchors employing an axially extending shaft withlaterally advanceable wings or lever arms such as for deployment in thecancellous bone may also be utilized.

Bone anchors will additionally include a connector, such an eyelet forconnection of a suture or other support line. The eyelet is preferablychangeable from a first configuration in which the suture or othersupport line may be freely advanced axially therethrough, such as forinitial connection of the support line to the anchor as well as forpermitting adjustment of the location of the implant prior to lockingthe implant to the bone anchor. A variety of bone anchors are known inthe art, which accommodate adjustment between a locked and an unlockedconfiguration, through the use of a variety of structures such ascompression screws, cam surfaces, interference engagement surfaces, andthe like.

Referring to FIG. 4A, a first bone anchor 64 is illustrated in positionat a first attachment site 62 on the clavical 60. A second bone anchor68 is illustrated at a second attachment site 66, on the sternum.

Although the present illustration shows the bone anchors in positionprior to introduction of the implant, the sequence of steps can bemodified. Accordingly, the implant can be positioned prior toinstallation of the bone anchors, or in between installation of a firstof the bone anchors and a second of the bone anchors, depending uponclinical choice.

The distal end 70 of the outer tunneling sheath 34 is illustrated inFIG. 4A as having been introduced through a percutaneous access site 72.The outer tunneling sheath 34 is advanced distally through the accesssite 72, and manipulated by manual palpation from the access site 72inferiorly, making a medial turn, and then inclining superiorly towardsthe clavical. Navigation may be accomplished using a combination ofmanipulating the tissue orientation, as well as bending or steering theouter tunneling sheath 34 by manual palpation through tissue.

For the advancing step, the outer tunneling sheath 34 may be providedwith a distal tip, such as a blunt dissection obturator tip (not shown)or a tissue cutting tip that may be utilized to dissect a pathwaythrough tissue. The obturator tip or dissection tip may be proximallyaxially retracted from the outer tunneling sheath 34 once the distal end70 is at a desired location such as that illustrated in FIG. 4B. At thattime, the assembly of the implant 30 and implant sleeve 32 may beadvanced distally through the outer tunneling sheath 34.

Referring to FIG. 4B, the distal needle 48 has been advanced from thedistal end 70 of the outer tunneling sheath 34. At this point, theanchor 68 may be under direct visualization through the anchor accesstract, thus permitting direct visualization as the needle 48 is advancedthrough the aperture or other interlocking structure on the bone anchor68. Needle 48 is thereafter retracted from the bone anchor 68 to removeslack in the distal support line 46 and also advance the basket 36 intoapproximately the desired position within the outer tunneling sheath 34.

Referring to FIG. 4C, the outer tunneling sheath 34 may be proximallyretracted and removed from the patient. The implant sleeve 32 may beleft in place over the basket 36, or may also be retracted, exposing thebasket 36 to tissue. The distal support line 46 is clamped or held by aclinician, to prevent it from escaping from the anchor 68, which has notyet been locked down on the distal support line 46. For this purpose,the connector on the bone anchor may be provided with a reversible lock,to allow temporary lock down on the support line and release to allowfinal adjustment before permanent lock down. Alternatively, the implantmay be packaged in a kit along with one or two temporary adjustable lockdown devices which can, be removed and discarded following finaladjustment and locking of the support lines.

Following removal of outer tunneling sheath 34, the proximal supportline 42 will exit the patient at access site 72. The proximal needle 44may be thereafter be advanced back through the access site 72, andtunneled subcutaneously in the direction of the lateral anchor 64. Thetissue tract which was formed for the implantation of lateral anchor 64may be utilized for direct visualization as the proximal needle 44 isadvanced through the locking aperture on anchor 64, to produce theconfiguration schematically illustrated in FIG. 4D.

At this point, the proximal support line 42 and distal support line 46may be placed alternately under tension, to advance the basket 36 backand forth along the tissue tract, until the desired positioned isreached. For this adjustment step, it may be desirable for the implantsleeve 32 to still cover the basket 36, to minimize tissue trauma. Forthis purpose, the implant sleeve 32 may be provided with an axiallyelongated indentation, perforation, or other modification to the wall oftubular body 50, to permit the implant sleeve 32 to be split and peeledaway from the proximal support line 42 as will be appreciated by thoseof skill in the art. When configured as a peel away sheath, the implantsleeve 32 may be provided with a pull tab or other handle at itsproximal end, preferably centered approximately 1800 apart from theperforation line, indent or other modification to facilitate tearing ofthe implant sleeve 32. In this configuration, the basket 36 may be moveduntil it has reached a desired location. The bone anchors 64 and 68 maybe advanced from an unlocked to a locked configuration, and the excesslength of the proximal support line 42 and distal support line 46 may besevered at about the respective bone anchor. The tissue tracts formedfor the implantation of the two bone anchors and for access by the outertunneling sheath 34 may thereafter be closed in accordance with standardtechniques.

Although the procedure described above involved implantation of a singleimplant 30, two or three or four or more implants 30 may also beimplanted, as has been discussed. Each implant may be tunneled through aunique tissue tract, and be attached to either the same bone anchors 64and 68 as have been discussed, or to one or two or three or four or morebone anchors, positioned elsewhere on the clavical, ribs or sternum. Thedesirability of including more than one implant 30 is a matter ofclinical choice, taking into account the patient and the desired result.

The result of various factors such as tissue elasticity and momentumcauses normal tissue to respond in a relatively predictable manner, tomovement by the patient. Depending upon the desired clinical result, itmay be desirable to modify the implant described above to increase thepotential range of inferior superior axis motion. This may beaccomplished in a variety of ways, one of which is illustratedschematically in FIG. 5.

Referring to FIG. 5, a sling 36 is illustrated in position and securedby a proximal support line 42 to a lateral anchor 64, and by a distalsupport line 46 to a medial anchor 68. At least a first strain relief 74is provided in communication with the proximal support wire 42, and atleast a second strain relief 76 is provided in, communication with thedistal support line 46. As used herein, strain relief refers to astructure or a material which permits temporary elongation of theeffective axial length of the support line, in response to an increasein load, and returns to an original elongation following removal of theload. Thus, strain relief 74 and 76 may in their simplest form, comprisea spring, or at least a section of elastic material, which can beelongated under load and will return to its original configurationfollowing removal of the load.

The proximal support line 42 may be provided with one or two or three orfour or more discrete strain relief 74, or the entire length of thesupport line 42 may function as a strain relief, such as by constructionfrom a helical spring, or an elastically deformable material. The sameconfigurations can be utilized for the distal support line 46.Alternatively, the strain relief 74 and 76 may be constructed as a partof or attached to the bone anchors 64 and 68. As a further alternative,the sling 36 may be constructed of a material and/or using a weavepattern that permits elastic deformation under load. For example, sling36 may comprise a plurality of generally parallel extending filamentswhich connect for example at each of the end points 38 and 40 of thebasket 36. Each filament may comprise a zigzag construction. or ahelical construction, or comprise an elastic material, such that is maybe elongated under load but not deformed beyond its elastic limit

The performance of the implant 30 incorporating one or more stain reliefconstructions 74 and 76 can be seen schematically with respect to FIG.6. The strain relief 74 and 76 create a bias to return in the direction80 which is generally superior, with a posterior inclination. The normalreference line 82 may be temporarily changed such as 284 undersignificant loading, but will return to 82 under the influence of theelastic force generated in the direction 80.

In accordance with alternative implementations of the invention, ananchor is positioned on the pectoralis fascia on the chest wall beneaththe breast mass. One example or corollary to this is the underwire of abra. The underwire can be semicircular or a full circle. It can bemalleable or rigid depending upon the support required. A fewembodiments of the support ring are pictured in FIGS. 7A-7C.

In FIG. 7A, a full ring is depicted, in FIG. 7B a semicircular or arcring is pictured. Note the attachment points to the chest wall X₄, X₅. Astraight support is seen in FIG. 7C.

The material properties of these constraints in FIG. 7 preferably permitdelivery to the chest wall through a tube at appropriate diameter.

In one embodiment, an incision is made in the skin beneath the pendulousof the breast mass in the midline, Z₁ (FIG. 8) large enough to acceptthe delivery tube. The incision is defined by the line Z₂ Z₃ in FIG. 8A.The breast mass must now be dissected in a blunt fashion from thepectoralis fascia, at the level where the support ring in FIG. 7 is tobe placed. The desired intercostal level can be identified using varyingforms of imaging before or during the procedure. In one embodiment, ablunt dissecting tool is the used, delivered through the aforementionedtube (FIG. 9).

The blunt dissector in FIG. 9 can be moved in a plane coincident withthe chest wall through positions D, E, F in FIG. 9, or any otherpositions, as a means of clearing the fascia of the pectoralis muscle.The ring or support structure (FIG. 7) is delivered, though the tube inFIG. 9 after the blunt dissector FIG. 9, has been removed.

In FIG. 10, the ring depicted in FIG. 7A has been placed inside thedelivery tube and is partially delivered onto the surface of thepectoralis fascia. As the ring leaves the tube, it opens. The bluntdissection described in FIG. 9 facilitates the rings positioning anddelivery. Once the ring has been delivered (FIG. 11), it will need to beaffixed to the chest wall. This can be done using suture, staples,clips, screws or wire, or any other type of fastener.

Each point of fixation of the support structure to the fascia ofpectoralis muscle serves a dual function. It holds the ring to the chestwall as well as providing a point of attachment for support devices thatwill bold the pendulous of the breast mass.

Percutaneous Minimal Mammoplasty

Methods of suspending the pendulous of the breast to the support ring orbar as seen in FIG. 7. Two concepts may be discussed. Method oftethering the suspension and fixation to the loose areola tissue of thependulous. In one embodiment, a sheet can be placed subcutaneouslyaround the breast without denervating the nipple. In the figure below(FIG. 12), a polymer sheet (G) acts as a parachute with the cords of thechute attached to the suspension ring.

In another embodiment, the polymer sheet could be replaced with polymerdiscs that are embedded into the areola tissue, each acting as anindependent suspension system as a separate point source. (FIG. 13).

Suspension Adjustment

The natural process of aging that lead to change in nipple trajectoryand the descended position of the pendulous mass does not slow down orchange. As a result, the suspension cords in FIGS. 12 and 13 may need tobe tightened. Therefore, the need for a noninvasive method to increasetension and decrease length of these parachute cords (FIGS. 12 and 13and other embodiments previously discussed) may be established. The needto perform this process without invasion, needle puncture, or openincision is preferable for obtaining a sustainable cosmetic result thatmaximizes patient satisfaction. In one embodiment, a pulley is used atthe attachment part on the support ring. (FIG. 14).

In FIG. 14B, a magnified view of the pulley is depicted the suspensioncord J, feeds into a spool K, contained within the housing L. The motorfor the pulley is activated by an externally applied magnetic field. Asa result, adjustments can be made in the awake patient, post operativelywithout sedation at any time.

Anchoring

The clavicle superiorly, the sternum medially and ribs at any level canact as bone anchor points of fixation for any of the embodiments herein.Given that the nipple is preferably redirected in a three-dimensionalspace, therefore, an anterior-posterior, cranialcaudial, andmedial-lateral degree of adjustment is preferably accomplished.Redirection of the nipple trajectory, repositioning of the pendulousrelative to the chest wall is preferably accomplished without cosmeticdeformity of the skin surface or dimpling of the nipple. To this end,multiple fixation points with tissue anchors in the areola tissue (orpendulous) may be required.

Referring to FIG. 15 the bony anatomy available for attachment includesthe First rib, Clavicle, and Manubrium of the sternum (superior medial).

The first rib and the clavicle define the best and most accessible bonyanchor points for superior fixation. These structures are readilypalpable through the soft tissue that overlays them, even in obesepatients. Although vascular and peripheral nervous system tissue liesproximate to these bony structures, the posterior nature of thesestructures and bone density makes them ideal fluoroscopic landmarks forpercutaneous placement of bone anchors.

The articulation of the clavicle, first rib with the sternum and theanatomic structure known as the manubrium of the sternum provides asuperior medial fixation point for a bony anchor. This point would lenda superior medial change in trajectory to the nipple.

One could easily envision bony anchor points at points X_(1→)X_(n) alongthe clavicle in FIG. 16 and subsequent vectors that would result inassociated change in nipple trajectory associated with the positions ofthe soft tissue anchors.

Soft Tissue Anchors:

The properties of soft tissue anchors vary depending upon their locationand function. A first type of anchor is for the areolar tissue (breastpendulous). Other tissue anchor locations will be considered separately.They include the pectoralis muscle, and facial planes that invest riband chest wall structures.

Areolar (Pendulous Anchors)

Areolar tissue is unique relative to other tissues in the body. It is inessence fatty tissue that has an increased amount of connective tissue,enervation, as well as ducts. This extra structure lends an increase ofoverall structure and compliance as well as increases tear out force,relative to pure fatty tissue, yet it certainly is less than muscle orfascia in terms of strength.

The tissue anchor may be placed percutaneously and at one end beattached to the bony anchor at the proximate end. The distal end of thetissue anchor would be embedded into breast tissue in one embodiment ofthe device (FIG. 13).

Another embodiment at the distal end of the tissue anchor embeds into apolymer sheet that cups the breast as in FIG. 12. A third embodiment ofthe distal tissue anchor is as follows. A hollow polymer tube or two orthree or more tubes are inserted into the pendulous of the breast. Thistube has attachment sites for the distal end of the tissue anchor asbelow. These tubes could be easily placed using percutaneous puncturesin the pendulous of the breast. They would need resistance to pullthrough. They could be affixed to the areolar tissue (if needed) usingbiological glue or suture, electrocautery device or other. (FIG. 17).Any bony fixation point could be connected to any point along a tube asin FIG. 18.

The support cable or wire (DI) in FIG. 18 would be placed percutaneouslyin a manner similar to threading a retention suture through any largetissue mass, entry point near bony anchor subcutaneous path throughbreast tissue and distal end threaded into attachment sites in thepolymer (or alloy) tube, the need the through skin and the cable istensioned and cut so the cable would recess subcutaneously.

Cables:

The connections between bony and tissue anchors need to provide supportfor change in nipple trajectory as well as prevent pull through. Theymay not be rigid structures but could be. One embodiment of the devicewould have the property of strain relief in the cables so that if anactivity like jumping were to be encountered after implantation, thebreast (unconstrained externally) could move up and down naturallywithout fear of the device pulling through.

In one embodiment, the cables are made from Nitinol wires with springsof varying length, size and force constant (K) that act as strain reliefgauges. The spring segment of the cable is firm enough to providesupport but can stretch when leading by, for instance, jumping motion.

X₅ (FIG. 19) is the bony attachment point (proximal) and X₆ is thetissue anchor point (distal). The representation of this type of systemcan be seen in the figure that follows. In FIG. 20, the anatomicconfiguration is continued from previous diagrams. The tissue anchorlabeled F is smaller in size and eccentrically positioned to depict thefact that tissue anchors can be placed anywhere in the breast tissue.

In another embodiment, the tissue anchor is not a polymer or alloy tubebut rather a mesh basket that is constrainable into a percutaneousdelivery tube as initially depicted in FIG. 16. The mesh basket orteardrop or ellipse or spherical shape would be porous and allow tissueinvagination and scar tissue anchor on an acute subacute and chronicbasis.

In FIG. 21A, an elliptical basket made of Nitinol mesh is pictured, inan unconstrained configuration. In FIG. 21B, the same distal tissueanchor is constrained within a tube undeployed. One could envision thistube being used as a percutaneous conduit to connect the proximate endof the cable to the final, position of the tissue anchor. The anchorcould be filled with bioglue or adhesive by either percutaneous stick orif the connector tube (cable) was hollow, then by direct injection. Thesize and shape of the tissue anchor would be proportional to theintended position in the breast tissue and the size and shape of thependulous. In addition, in one embodiment, the size and shape of thetissue anchor is variable and can be adjusted in situ.

In one embodiment, the tissue anchor would be placed in an openconfiguration, grab tissue, and then close around the tissue to grab andincorporate it within the mesh as in FIG. 22. In FIG. 22A, the device ordistal tissue anchor is in an open configuration, the distal end of thedevice is like a lasso and wire labeled A is used to close the distalloop and act to grab tissue. Although not pictured, the basket is porouseither as a mesh or solid perforated sheet. In another embodiment, thepolymer or alloy tubes are perforated and the method of attachment isperformed by threading a tube from the bone anchor to the polymer tubeand delivering or expanding the mesh device distal to the perforatedportion in the polymer tube, as below.

In an additional embodiment, the connective tissue, distal cable and thepolymer tube is connected by passing a coaxial system through thepolymer tube hole and deploying a cable with supra structure at itsdistal end as pictured in FIG. 24. This structure serves to act as anattachment or pull through point to the polymer tube while additionallyacting as a tissue anchor distal to the polymer tube.

In FIG. 24A, the distal end of the cable has been inserted through thehole in the polymer support tube and a plurality of wires at its distalend are unsheathed as a means of securing the tube and acting asunsheathed tissue anchor. In 24B, the plurality of wires are constrainedwithin the delivery tube. In 24C, the delivery tube remains in placewith the plurality of wires deployed.

Desirable properties of the device include 1) Percutaneous placement. 2)Image guided, fluoroscopy drive, also could consider ultrasound—possiblyadjustments in office or surgery center. 3) Strain relief on the supportlines and/or sling attached to anchors so that normal motion of breastundisturbed. 4) Adjustable—either minor outpatient procedure or externalmagnet or electrical signal drives cable reel near bone anchors. 5)Implant does not change texture or feel of the breast to manualpalpation. 6) Cannot interfere with mammography images 7) MRIcompatible. 8) Minimal tissue dissection required for placement andstabilization. 9) Tissue anchor insertion cannot interfere with nipplesensation or lactation. 10) Patient should be able to jump on atrampoline without “fear of device” damage, and with natural motion ofthe breast tissue.

What is claimed is:
 1. A method of supporting tissue of a breast,comprising: introducing a flexible support to a position between a chestwall and the breast; introducing at least a first and a second softtissue anchors into breast tissue beneath the support; suspending thefirst soft tissue anchor from a first location on the support with afirst suspension element to support the breast tissue; and suspendingthe second soft tissue anchor from a second location on the support witha second suspension element to support the breast tissue, wherein aftersuspending the first soft tissue anchor and suspending the second softtissue anchor the first soft tissue anchor is suspended solely by thefirst suspension element beneath the support and the first suspensionelement and the second soft tissue anchor is suspended solely by thesecond suspension element beneath the support and the second suspensionelement.
 2. The method of claim 1, wherein the support comprises acurved segment from a first end of the support to a second end of thesupport.
 3. The method of claim 1, wherein the support comprises agenerally linear configuration.
 4. The method of claim 1, wherein atleast one of the suspension elements comprises a suspension cord.
 5. Themethod of claim 4, wherein the suspension cord comprises at least onestrain relief.
 6. The method of claim 5, wherein the strain reliefcomprises a spring.
 7. The method of claim 4, wherein the suspensioncord comprises Nitinol wire.
 8. The method of claim 1, wherein at leastone of the soft tissue anchors is anchored to one of the groupconsisting of: areolar tissue, a pectoralis muscle, and a fascial planesoverlying rib and chest wall structures.
 9. The method of claim 1,wherein at least one of the soft tissue anchors is a mesh basket. 10.The method of claim 1, wherein at least one of the soft tissue anchorsis a polymer tube.
 11. The method of claim 1, wherein the support isattached to one of the group consisting of: a first rib, a clavicle, anda manubrium of a sternum.
 12. The method of claim 1, further comprisingadjusting a tension of the suspension elements after the soft tissueanchors are suspended from the support.
 13. The method of claim 1,wherein adjusting the tension of the suspension elements is accomplishednon-invasively.
 14. The method of claim 1, wherein the support comprisesa full ring.
 15. The method of claim 1, wherein the support has anelongate shape.
 16. The method of claim 1, wherein suspending the firstand second soft tissue anchor support the breast tissue without cuppingthe breast tissue.
 17. The method of claim 1, wherein the first softtissue anchor comprises a disc.
 18. The method of claim 1, wherein afterthe suspending the first soft tissue anchor and the second soft tissueanchor each act independently as point anchoring sources to support thebreast tissue.
 19. A method of supporting tissue of a breast,comprising: introducing a support to a position between a chest wall andbreast tissue; introducing at least a first and a second soft tissueanchors into the breast tissue beneath the support; suspending the firstsoft tissue anchor from a first location on the support with a firstsuspension element to support the breast tissue; and suspending thesecond soft tissue anchor from a second location on the support with asecond suspension element to support the breast tissue, wherein afterthe suspending the first soft tissue anchor and suspending the secondsoft tissue anchor the first soft tissue anchor is suspended solely bythe first suspension element beneath the support and the firstsuspension element and the second soft tissue anchor is suspended solelyby the second suspension element beneath the support and the secondsuspension element.